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Silent Nite Sleep Appliance with the Glidewell Hinge is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. It is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

The Silent Nite Sleep Appliance with the Glidewell Hinge is a mandibular advancement device. It holds the mandible in a protrusive position to increase the patient's ability to exchange air and decrease air turbulence, thus improving airflow during sleep. The device consists of upper and lower trays, which are fabricated using a biocompatible dual-layered thermoplastic material, and an engaging mechanism, which is the Glidewell Hinge (biocompatible medical grade stainless steel bars), and band lugs and hooks for attaching the optional orthodontic (elastic) bands, which are provided as accessories. The trays consist of a soft polyurethane inner layer that provides patient comfort and a hard polyester outer layer for durability. The hinge is adjustable by turning an inner adjustment screw with a hex driver, enabling the amount of mandibular advancement prescribed by the clinician. The design allows for the advancement of the mandible to be adjusted (increased or decreased) in 0.25 mm increments up to 10 mm. The orthodontic bands accessories are used to aid in holding the mouth closed. The end result, a forward position of the jaw, is the same as the predicate, however, the method of action of the predicate device and subject device are slightly different. Silent Nite Sleep Appliance with the Glidewell Hinge's method of action is identical to the Reference device and both use orthobands. Without orthobands, the patient's mouth can open during sleep which allows the tongue to fall back into the airway. The orthobands help keep the mouth closed to avoid this. With just a slight protrusion, the orthobands can be placed on the provided hooks. More protrusion requires the orthoband to be placed on the forward hook and the band lug. The device is customized to conform to the patient's upper and lower dentition based on the clinician's prescription. Upon receipt of the prescription, models for the trays are made and used during the thermoforming fabrication of the upper and lower trays. The difference between the Silent Nite Sleep Appliance with the Glidewell Hinge and the Primary Predicate Silent Nite sl is the mechanism connecting the trays: The new device's stainless steel hinge allows adjustment within the mechanism, while the Predicate's adjustment requires changing the plastic connectors. This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep.

The provided text is a 510(k) Summary for a medical device called the "Silent Nite Sleep Appliance with the Glidewell Hinge." It describes the device, its intended use, and how it compares to a predicate device to establish substantial equivalence for FDA clearance.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them, primarily focusing on the engineering and material performance rather than clinical efficacy studies, as this is a 510(k) submission for a physical device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria detailed in the document are primarily related to the device's functional integrity, fit, and material biocompatibility. Clinical efficacy (e.g., reduction in AHI) is established through the similarity to the predicate device, not through new clinical trials described here.

1. Table of Acceptance Criteria and Reported Device Performance:

• Device design allows for advancement to be adjusted (increased or decreased) in 0.25 mm increments up to 10 mm. This indicates the function works as intended. |
  | | Maximum hinge displacement (mm) correct | - Verification testing conducted by Prismatik Dentalcraft, Inc.
• Specific maximum displacement (up to 10mm) is stated, implying it meets this range. |
  | | Hinge placement/positioning correct | - Verification testing conducted by Prismatik Dentalcraft, Inc. |
  | | Device fits and retains to the model | - Validation testing showed acceptable performance.
• Customized to conform to the patient's upper and lower dentition based on clinician's prescription; models are made and used during thermoforming fabrication. |
  | | Hinge is well attached to the trays | - Validation testing showed acceptable performance. |
  | | Device's final finish is smooth and free of roughness or burs | - Validation testing showed acceptable performance. |
  | Biocompatibility | Materials meet ISO 10993 requirements (trays) | - ISO 10993 testing performed on Thermoforming Sheet Materials (documented in Reference device K200125).
• Material is safe and biocompatible for "fabrication of orthodontic and dental appliances."
• Tests include Cytotoxicity and Irritation (implied, as it matches predicate's requirements). |
  | | Materials meet ISO 10993 requirements (stainless steel hinge)| - ISO 10993 testing conducted on the stainless steel hinge component:
  • In vitro Cytotoxicity (Part 5): Met requirements.
  • Guinea Pig Maximization Sensitization (Part 10): Met requirements.
  • Oral Mucosal Irritation in Hamsters: 14 days (Part 10): Met requirements.
• Test article deemed safe and biocompatible for the intended use. |
  | Manufacturing Process | Verification and validation of manufacturing process | - Verification and validation performed by Prismatik Dentalcraft, Inc.
• Led to acceptable performance for functional attributes and physical finish. |
  | "Clinical" Equivalence | Intended uses are the same as predicate | - "To reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older." - Confirmed as same. |
  | | Mechanisms of action are the same | - "Holds the mandible in a protrusive position to increase the patient's ability to exchange air and decrease air turbulence, thus improving airflow during sleep." - Confirmed as same. The minor difference in how the action is achieved (adjustability mechanism) was addressed by V&V testing. |
  | | Materials for trays are the same as predicate | - "Heat-sensitive impression dual-layer material." - Confirmed as same. |
  | | Manufacturing methods similar | - Confirmed as similar. |
  | | Non-sterile | - Device is non-sterile. - Confirmed as same as predicate. |
  | | Prescription Use Only; Single patient use, removable, reusable | - Confirmed as same. |
  | | Environment of Use: In patient's home or sleep laboratory | - Confirmed as same. |

Study Details Proving Device Meets Acceptance Criteria

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify discrete sample sizes for the functional and manufacturing verification/validation tests. These types of tests typically involve testing a representative number of units from manufacturing runs.
The data provenance is from Prismatik Dentalcraft, Inc. (the manufacturer), indicating these are internal company tests, likely conducted as part of their quality management system for product development and release. The tests are prospective in the sense that they are performed on newly manufactured devices to confirm design specifications and manufacturing quality.
No specific country of origin for the data is mentioned, but the manufacturer is based in Irvine, CA (USA), implying the testing was conducted under US regulatory considerations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This document details engineering and biocompatibility testing, not clinical studies requiring expert ground truth in the diagnostic sense. Therefore, experts in this context would be test engineers, quality control personnel, and lab technicians. Their qualifications are not specified but would be implicit in their roles within the manufacturing and testing environment (e.g., trained in verification/validation, ISO standards, good laboratory practices).

4. Adjudication Method for the Test Set:
Not applicable in the sense of clinical image review or diagnostic agreement. Adjudication would be based on objective criteria defined in the test protocols (e.g., measurement within tolerance, pass/fail result for biocompatibility tests). Deviations would be addressed through standard quality control and engineering procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No MRMC comparative effectiveness study was described or required. This is a 510(k) submission for a physical medical device, not an AI/software device that would typically involve human reader performance studies. The substantial equivalence relies on the device's design, materials, and mechanism of action being sufficiently similar to a legally marketed predicate, backed by engineering and biocompatibility testing. The predicate device's clinical effectiveness is already established.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This isn't an algorithm or AI device. The testing described is for the physical device itself.

7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by engineering specifications, material standards (ISO 10993), and functional design requirements. For example, the ground truth for "mandibular advancement function correct" is that the device can reliably achieve the specified 0.25 mm increments up to 10 mm. For biocompatibility, the ground truth is "met requirements of each test" according to ISO 10993.

8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning product that requires a training set.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, no training set is relevant for this type of device.

In summary, this 510(k) submission establishes substantial equivalence for a physical medical device based on engineering verification and validation, biocompatibility testing, and comparison of design and intended use to a predicate device, rather than clinical efficacy trials or AI/software performance studies.

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The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor is intended to reduce snoring and mild to moderate obstructive sleep apnea (OSA) and monitor patient usage in an adult population.

The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are simple hardware devices. They are oral appliances and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.

The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are intraoral devices used for treating and mild to moderate Obstructive Sleep Apnea (OSA). They consists of two custom fitted trays which fit over the upper and lower dentition of a patient and engage by means of adjustable metal screws or lugs. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. Additionally nasal dilator buttons are attached to the upper appliance, that when engaged stretch the nasio-label tissue in order to increase space in the nasal airway passage thus reducing tissue obstructions that aid in reducing snoring and OSA.

The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint and by the base material engaging the undercuts of the teeth.

The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

Additionally, the devices include the Dentitrac ® patient monitoring system as characterized under the Braebon Dentitrac MAF 2557 to help monitor patient compliance to prescribed usage.

The provided text describes a 510(k) submission for the "OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor". This submission focuses on demonstrating substantial equivalence to a predicate device and does not involve a clinical study with specific acceptance criteria that would typically be found in direct performance evaluations of a new medical device's efficacy or diagnostic accuracy. Instead, the "acceptance criteria" are related to established safety and performance standards for similar devices and the successful integration of the monitoring system.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe a test set or data provenance in the context of a clinical study or performance evaluation with human subjects for the OASYS device itself. The evidence presented is primarily based on:

• Comparison to predicate devices: This involves structural and functional similarities, and the predicate device (K030440) served as the primary benchmark.
• Non-clinical testing: This refers to laboratory-based evaluations for biocompatibility, electrical safety, software, and general performance. The text does not specify sample sizes for these tests (e.g., how many units were tested for biocompatibility, though such tests are typically conducted on representative samples).
• Reference to Master File (MAF 2557): The DentiTrac® Patient Monitoring System's specific testing details (biocompatibility, electrical, performance, and characterization) are contained in a larger "Master File," which is a confidential document submitted to the FDA. The details of any test sets or sample sizes within that MAF are not disclosed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the submission is a 510(k) for substantial equivalence, relying on non-clinical testing and comparison to existing devices rather than a de novo clinical study requiring expert-established ground truth on a test set.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is an oral appliance for treating snoring and sleep apnea, and a DentiTrac® monitoring system. It is not an AI-assisted diagnostic or assistive technology that would involve "human readers" or an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The DentiTrac® system monitors patient usage; it's a data collection system rather than an algorithm performing a diagnostic or assistive function that would have "standalone performance" in the context of AI.

7. The Type of Ground Truth Used

For the biocompatibility and performance testing, the ground truth is based on established international and national standards (e.g., ISO 10993-1, ISO 14971) and internal requirements/specifications. For the DentiTrac® system, the ground truth for its performance would be against its own specifications, validated as acceptable in MAF 2557, likely using calibrated instruments for accuracy of usage time measurement. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is not an AI/machine learning system that requires training data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as #8.

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The Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea.

The Healthy Sleep Appliance is a mandibular repositioning oral appliance used to treat snoring and mild to moderate obstructive sleep apnea. It is composed of an upper and a lower tray made to fit the occlusal surface of the teeth. These full arch trays are connected to each other by stainless steel arms that are set to conform to the predetermined occlusal relationship of the upper and lower arches. These arms have an adjusted length that can be adjusted as needed to exert a forward force on the lower jaw and advance the mandible relative to the maxilla. The advancement of the lower jaw increases the patient's pharyngeal space which facilitates improved air exchange.

This looks like a medical device submission, specifically a 510(k) summary for the "Healthy Sleep Appliance." The document describes the device, its indications for use, and a comparison to a predicate device. It also includes a "Clinical Testing Summary" which details a small study.

Here's an analysis of the provided information to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the device's performance in a quantitative way (e.g., "The device must reduce AHI by X% in Y% of patients"). Instead, the study aims to demonstrate substantial equivalence by showing similar outcomes to existing oral appliance therapy and the predicate device.

The reported device performance from the 7-patient study is as follows:

Note: The document explicitly states: "Note Subjects # 1, 2, 4, and 5 were diagnosed with severe OSA and Oral Appliance therapy . was not recommended for them." This suggests that while their AHI improved significantly, these specific cases might fall outside the device's intended population for recommendation, which is for mild to moderate obstructive sleep apnea. However, the data is presented, showing the device's effect across these patients.

The overall conclusion is that the device "was well tolerated and effective with individuals with mild to moderate OSA that had not tolerated CPAP."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 7 patients.
• Data Provenance: The document does not specify the country of origin. It appears to be a prospective study, as it describes a "seven patient clinical study was conducted comparing the Healthy Sleep Appliance vs. the predicate Herbst Splint (K083209)." This implies the study was specifically undertaken to gather data for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study involved polysomnography (PSG) for pre- and post-treatment evaluation, which is the standard diagnostic test for OSA. However, the document doesn't detail who interpreted these PSGs or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not an AI device. Therefore, an MRMC study with AI assistance is not applicable and was not performed. The study is a direct comparison of the device (Healthy Sleep Appliance) against a predicate device (Herbst Splint) in terms of patient outcomes (AHI reduction).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not an AI device. Therefore, a standalone algorithm performance study is not applicable and was not performed. The device is a physical oral appliance.

7. The Type of Ground Truth Used

The ground truth for the effectiveness of the device in reducing sleep apnea was established through polysomnography (PSG), which is considered the gold standard for diagnosing and assessing the severity of sleep apnea. The specific metric used was the Apnea/Hypopnea Index (AHI).

8. The Sample Size for the Training Set

There is no training set in the context of an algorithm. This is a physical medical device. The "training" for establishing its effectiveness comes from the clinical study on the 7 patients and a review of existing literature (Ferguson, et.al., Oral Appliances for Snoring and Obstructive Sleep Apnea: A Review).

9. How the Ground Truth for the Training Set Was Established

As this is not an AI device, the concept of a "training set" and its ground truth establishment does not apply in the conventional sense. The "ground truth" for the device's performance evaluation was established by measuring AHI through polysomnography in the 7 human subjects before and after using the device.

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The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

The Acrylic Herbst Appliance is comprised of custom-fabricated acrylic splints (methylmethacrylate) which are connected bilaterally via a telescoping Herbst mechanism (stainless steel).

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary and FDA clearance letter for the Acrylic Herbst Appliance, which establishes substantial equivalence to existing predicate devices.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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